CCTIS provides IT services for federal health agencies, research institutions, and healthcare organizations. It designs and delivers secure, scalable, and compliant IT solutions that improve how health data is captured, shared, and used, supporting clinical research, public health, and patient outcomes. Its offerings include health and clinical research informatics, data strategy and advanced analytics, AI/ML and intelligent automation, cloud and application modernization, cybersecurity, and DevSecOps. CTIS combines health-domain expertise with enterprise technology to turn complex health and mission challenges into measurable, outcome-driven results. It is trusted by NIH, FDA, HHS, and DoD Health environments, and aims to bridge health, data, security, and innovation in a responsible, effective way.
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What happened when Women Leaders stepped Beyond the Blueprint event? What does it take for a woman to step into leadership, earn trust, carry responsibility, and continue growing when the path ahead is unfamiliar? That question came to life at "Beyond the Blueprint: Perspectives of Women in Leadership", an in-person event hosted by IAICC in collaboration with CTIS on July 23, 2026. The evening brought together leaders, professionals, and community members for a candid discussion on purpose, resilience, trust, empathy, reinvention, and the realities women face in leadership. A Leadership Journey That Was Never Planned The program opened with introductions to IAICC and CTIS, setting the stage for an evening centered on relationships, collaboration, and shared learning. The highlight of the evening was a fireside conversation led by Dr. Shankar Rachakonda, Executive Chairman, IAICC US & Mid-Atlantic Region, with Ms. Bharti Shah, CEO at CTIS Inc. Her story demonstrated that leadership is not always the result of a carefully designed career path. Sometimes, it begins when circumstances demand courage. Ms. Bharti Shah reflected on her journey from India to the United States, motherhood, early childhood education, and the leadership of a health information technology company. She described learning the business by observing, asking questions, listening to experienced colleagues, and trusting the team around her. When the responsibility of leadership eventually came to her, she did not claim to have every answer. She chose to ask questions, trust the people around her, and learn one day at a time. Her experience showed that leadership can be built through humility, care, consistency, and the willingness to keep learning. Women Leaders Are Rewriting Their Own Stories A panel discussion followed the fireside chat. The panel discussion, moderated by Dr. Aparna Arvind, CEO at Christopher Leah Consulting, Inc., brought together Ms. Bharti Shah, CEO at CTIS Inc., Ms. Sudha Mathew, President at TalTeam, and Ms. Anisha Agarwal, Director at Aurrera Health Group. Ms. Bharti Shah spoke about channeling personal pain into purpose, creating realistic expectations for her team, protecting employee wellbeing, and building future leaders through transparency, respect, and collaboration. Ms. Sudha Mathew shared her transition from language studies and teaching into technology entrepreneurship. She described the risks of entering an unfamiliar industry, the effort required to earn credibility, and the importance of certifications, culture, consistency, and hiring the right people when building a company. Ms. Anisha Agarwal offered the perspective of a younger leader in behavioral health and addiction policy. She spoke about trusting her expertise, leading people who may be older or more experienced, and creating accountability through curiosity, empathy, transparency, active listening, and psychological safety. Dr. Aparna Arvind connected these experiences to the broader realities of women in leadership. She explored several themes relevant to women in leadership, including imposter syndrome, changing personal narratives, mental fitness, mentorship, burnout, emotional intelligence, and the need for leaders to remain adaptable. The discussion made one point clear: there is no single blueprint for women to succeed in leadership. Leadership growth often begins when women stop limiting themselves to an older version of who they are. What Women in Leadership Looked Like in the Room Throughout the evening, empathy appeared repeatedly as a defining leadership quality. The audience questions brought greater depth to the evening. They discussed bias, unequal expectations, the pressure to prove credibility, the value younger professionals bring, and the importance of mentors, coaches, families, male allies, boards, and teams. The event closed with reflections, networking, and a shared commitment to continue amplifying women's stories and building stronger relationships. The evening served as another example of IAICC's commitment to creating spaces where leaders can connect, learn, collaborate, and turn meaningful conversations into lasting relationships. Join IAICC membership and become part of a community where women leaders, entrepreneurs, professionals, and changemakers connect, collaborate, and create lasting impact together. Watch the Beyond the Blueprint event on YouTube for deeper insights into how women leaders navigate challenges, build credibility, and shape the next generation of leadership.
CTIS, Inc. has launched Trial SafetyXchange, a cloud-based SaaS solution designed to help small and mid-size pharmaceutical companies, biotech firms and contract research organisations meet the FDA's April 1, 2026 E2B(R3) compliance deadline. The platform converts Individual Case Safety Report files from the previous E2B(R2) format to the mandated E2B(R3) standard. The solution addresses a critical gap for organisations lacking enterprise systems, offering an immediately deployable compliance path at reduced cost. Trial SafetyXchange features a web-based interface requiring no downloads or IT infrastructure, automatically converting files and validating them against ICH and FDA implementation guides. CTIS, a women-owned small business with over 30 years of health IT experience, is offering complimentary access for a limited time. The company has raised $295 million to date.
CTIS, Inc. launches Trial SafetyXchange to help pharma companies meet critical FDA E2B(R3) compliance deadline. Affordable, cloud-based SaaS solution automates E2B (R2) to E2B (R3) conversion for small and mid-size pharma organizations ROCKVILLE, Md.-(BUSINESS WIRE)-CTIS, Inc., with more than 30 years of experience in Health IT and clinical research informatics expertise for government and industry clients, today announced the commercial availability of Trial SafetyXchange. The cloud-based software-as-a-service (SaaS) solution is purpose-built to help small and mid-size pharmaceutical companies, biotech firms, and contract research organizations (CROs) seamlessly convert Individual Case Safety Report (ICSR) files from the prior E2B (R2) format to the U.S. Food and Drug Administration (FDA)-mandated E2B (R3) standard ahead of the agency's April 1, 2026 compliance deadline. Trial SafetyXchange addresses a critical gap in the pharmacovigilance technology market. With the April deadline approaching, organizations that have not yet transitioned to E2B (R3) face potential regulatory consequences and penalties imposed by the FDA. For companies without an existing enterprise solution, Trial SafetyXchange offers a practical, immediately deployable path to compliance - at a fraction of the cost and human resource drain of traditional platforms. "Creating E2B R3 outputs from the ground up is highly complex and requires specialized expertise - it's not realistically achievable without the right technology, especially in light of the FDA's E2B R3 mandate," said Vaibhav Kothale, vice president and chief program and projects officer at CTIS. "With Trial SafetyXchange, we're enabling companies to meet the FDA mandate without investing in expensive enterprise systems. Our solution removes barriers to compliance by simplifying the ICSR format conversion process and significantly reducing its associated costs." Trial SafetyXchange was designed with ease of use in mind. The solution accepts existing E2B (R2) files, automatically converts them to the R3 format, and runs them through a robust built-in validation engine - all through a 100% web-based interface that requires no downloads, no IT infrastructure, and no prior technical training. Organizations can be up and running quickly and submit reports with confidence, knowing their files comply with both the ICH E2B(R3) Implementation Guide and the FDA's Regional Implementation Guide. "For more than 30 years, CTIS has been committed to making Health IT solutions that are both powerful and accessible. With Trial SafetyXchange, we're bringing the same depth of expertise we've built supporting the NIH and other federal agencies directly to small and emerging pharma companies that need it most," said Bharti Shah, CEO and chairwoman of CTIS. "No organization should face a compliance deadline without a viable path forward simply because they lack the budget of a large enterprise. We're proud to make Trial SafetyXchange available to the broader clinical research community." Trial SafetyXchange is available now. Organizations interested in learning more or scheduling a demo can visit www.trialsafetyxchange.com or contact the CTIS sales team at [email protected] or 240-499-2200. Take advantage of our Exclusive Launch Offer with complimentary access, available for a limited time. About CTIS, Inc. CTIS, Inc. is a Women-Owned Small Business (WOSB) headquartered in Rockville, Maryland, with more than 30 years of experience delivering Health IT solutions in support of clinical trials, hospitals, and research institutions. A trusted government contractor with a strong track record supporting federal agencies including the National Institutes of Health (NIH), CTIS specializes in clinical research informatics, safety reporting and monitoring, health data standards, and privacy and security solutions. The company is committed to creating secure, user-centered systems that reduce costs, accelerate drug development, and improve patient care. Learn more at www.ctisinc.com. Contacts. Press Contact Mehul Shah Modernization & Growth Director, CTIS, Inc. Phone: 301-948-3033 x2143 Email: [email protected] Website: www.ctisinc.com | www.trialsafetyxchange.com
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Industries
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Baltimore, MD
Founded
N/A
Find jobs on Simplify and start your career today
We update CTIS's jobs every few hours, so check again soon!Browse all jobs